Since Switzerland's Medical Devices Ordinance (MedDO) came into force, non-Swiss manufacturers must appoint a Swiss Authorised Representative (CH-REP) before placing any medical device on the Swiss market. Switzerland is no longer covered by your EU CE marking alone.
Switzerland is not a member of the European Union. Following the breakdown of negotiations over the Swiss-EU Institutional Framework Agreement, Switzerland's mutual recognition agreement with the EU for medical devices was not updated to cover EU MDR and IVDR. As a result, Swiss law now requires its own authorised representative — entirely separate from your EU AR.
The Swiss Medical Devices Ordinance (MedDO / ODim) came into force on 26 May 2021, aligning closely with EU MDR 2017/745 and IVDR 2017/746 in structure and requirements. However, it operates as independent Swiss law requiring independent Swiss registration and a CH-REP with a Swiss address.
Any manufacturer established outside Switzerland who places a medical device or IVD on the Swiss market must appoint a CH-REP. This applies to EU manufacturers as well as manufacturers from all other countries — including USA, UK, China, Japan, Australia and all other non-Swiss countries.
The CH-REP must be established in Switzerland and registered with Swissmedic. Unlike the EU where your EU AR can be based anywhere in the 27 member states, the CH-REP must have a Swiss address.
Swissmedic registration. The CH-REP registers your company and devices in the Swissmedic database — the Swiss equivalent of EUDAMED — before any device is placed on the Swiss market.
Legal representation. The CH-REP acts as your legal representative to Swissmedic and Swiss Cantonal Authorities for all regulatory correspondence, vigilance reporting and market surveillance matters.
Labelling compliance. Switzerland has specific labelling requirements including the CH-REP name and address on device labels, and language requirements for Swiss official languages (German, French and Italian depending on the canton).
Vigilance reporting. The CH-REP coordinates vigilance reporting to Swissmedic for serious incidents and field safety corrective actions involving your devices on the Swiss market.
Switzerland continues to accept CE marking under EU MDR and IVDR as the basis for Swiss market access. Your devices must carry a valid CE mark before the CH-REP can register them with Swissmedic. The CH-REP arrangement works alongside your existing EU MDR CE marking — the two systems complement each other.
This means you need two representatives for Europe: your EU AR covering the 27 EU member states, and your CH-REP covering Switzerland. NordMDR AB can provide both services under a single engagement, simplifying your compliance structure significantly.
While MedDO closely mirrors EU MDR in structure, there are Switzerland-specific requirements including the mandatory CH-REP with Swiss address, Swissmedic database registration separate from EUDAMED, Swiss-specific labelling with CH-REP details, vigilance reporting directly to Swissmedic, and Swiss official language requirements for labelling and IFU.
NordMDR AB provides CH-REP services for non-Swiss manufacturers. We handle Swissmedic registration, labelling compliance and ongoing Swiss regulatory obligations — combined with EU AR services if required. Fixed annual fee.
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